Continued deregulation in healthcare. Further changes in the Pharmaceutical Law

Another draft amendment to the Pharmaceutical Law has been added to the government's agenda. This is another deregulation project by the Ministry of Health. Last Tuesday (6 May) , the Council of Ministers adopted a draft amendment to the same act, abolishing overly formalistic requirements for a doctor to contact a pharmaceutical company to provide a free drug sample.

The draft, which was added to the list today (8 May), excludes the obligation imposed on companies to provide information on the planned place of delivery of medicinal products intended for sale in Poland to the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL).

As we read, this requirement is difficult to implement in practice, because "it is often impossible to clearly predict at the reporting stage the specific address of the wholesaler where the delivery of medicinal products will be made in the future months."

- At the same time, this is an obligation that is irrelevant from the point of view of monitoring the availability of medicinal products, and also involves duplicating data. Based on the data collected in ZSMOPL from daily reporting by pharmaceutical wholesalers, it is possible to determine the actual destinations of deliveries, which is sufficient from the point of view of monitoring the market for these products. Therefore, the responsible entity should not have to provide this information itself, since it results from ZSMOPL anyway - explains the drafter.

The date of adoption of the project by the Council of Ministers is planned for the second quarter of 2025.

The Ministry of Health emphasized in the justification of the project that the change in regulations implements the government's deregulation goal. The new regulations are to enter into force generally 14 days after publication in the Journal of Laws.

Last Tuesday, the government adopted another deregulation project of the Ministry of Health, also amending the pharmaceutical law. It assumes the removal of overly formalistic requirements regarding requesting the delivery of a free sample of a medicinal product.

Such an application to a sales or medical representative may be submitted by a person authorized to issue prescriptions, e.g. a doctor. Currently, they must submit an application with a handwritten or qualified electronic signature. The project assumes that there will no longer be such a requirement and it will be possible to apply for a drug sample in written and documentary form. This includes an e-mail message, text message, a conversation conducted on a messenger and a recorded telephone arrangement.

In addition, also on Tuesday, the government adopted other deregulation acts concerning, among others, the introduction of new services in the mObywatel application, reduction of court costs, favourable solutions for entrepreneurs subject to customs and tax control, and extension of the time to change the name after divorce.

In turn, the Standing Committee of the Council of Ministers was to hear further information from Minister Maciej Berek on the status of work on deregulation projects at its Thursday meeting. The next meeting of the committee is scheduled for Friday (9 May), where deregulation projects are also to be discussed.

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